Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 9:50 PM
Study NCT ID:
NCT05710627
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2023-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '100 patients will be enrolled in the TENEX group and 50 patients in the control group accounting for 10% rate of loss-to-follow-up. 10 pre computer-generated blocks, consisting of 15 patients in each block, will be generated. In each block, 5 patients will be assigned to CMM and 10 to the Tenex group. Patients will be assigned to each group by the order that computer has created.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-02-01', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Level', 'timeFrame': 'Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years', 'description': 'The difference in pain levels in patients before and after the procedure. Pain levels (NRS scale) recorded in the pre-operative visit will be compared to the pain levels at follow-up (FU) visits. The Numeric rating scale (NRS) is a pain screening tool used to assess pain severity using a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. Pain level scores will be summarized by study arm. Achievement of 50% reduction in pain level from baseline at 6 months post treatment will be considered successful.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life using the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)', 'timeFrame': 'Baseline (before treatment), 1 month, 3 months, 6 months, 1 year, and 2 years', 'description': "A comparative analysis between TENEX to conventional medical treatments will be conducted using the EQ-5D-5L. Walking, side-lying, sit-to-stand transfers, and medication utilization will be assessed. The EQ-5D-5L is a descriptive system which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1- digit number that expresses the level selected for that dimension. The digits for the five dimensions are combined into a five-digit number that describes the patient's health state. Results will be summarized by study arm."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Greater Trochanteric Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '17678660', 'type': 'BACKGROUND', 'citation': 'Segal NA, Felson DT, Torner JC, Zhu Y, Curtis JR, Niu J, Nevitt MC; Multicenter Osteoarthritis Study Group. Greater trochanteric pain syndrome: epidemiology and associated factors. Arch Phys Med Rehabil. 2007 Aug;88(8):988-92. doi: 10.1016/j.apmr.2007.04.014.'}, {'pmid': '32232066', 'type': 'BACKGROUND', 'citation': 'Baker CL Jr, Mahoney JR. Ultrasound-Guided Percutaneous Tenotomy for Gluteal Tendinopathy. Orthop J Sports Med. 2020 Mar 19;8(3):2325967120907868. doi: 10.1177/2325967120907868. eCollection 2020 Mar.'}, {'pmid': '21893483', 'type': 'BACKGROUND', 'citation': 'Del Buono A, Papalia R, Khanduja V, Denaro V, Maffulli N. Management of the greater trochanteric pain syndrome: a systematic review. Br Med Bull. 2012 Jun;102:115-31. doi: 10.1093/bmb/ldr038. Epub 2011 Sep 4.'}, {'pmid': '27139495', 'type': 'BACKGROUND', 'citation': "Mellor R, Grimaldi A, Wajswelner H, Hodges P, Abbott JH, Bennell K, Vicenzino B. Exercise and load modification versus corticosteroid injection versus 'wait and see' for persistent gluteus medius/minimus tendinopathy (the LEAP trial): a protocol for a randomised clinical trial. BMC Musculoskelet Disord. 2016 Apr 30;17:196. doi: 10.1186/s12891-016-1043-6."}, {'pmid': '26033462', 'type': 'BACKGROUND', 'citation': 'Chandrasekaran S, Lodhia P, Gui C, Vemula SP, Martin TJ, Domb BG. Outcomes of Open Versus Endoscopic Repair of Abductor Muscle Tears of the Hip: A Systematic Review. Arthroscopy. 2015 Oct;31(10):2057-67.e2. doi: 10.1016/j.arthro.2015.03.042. Epub 2015 May 29.'}, {'pmid': '37535779', 'type': 'BACKGROUND', 'citation': 'Wahezi SE, Patel A, Yerra S, Naeimi T, Sayed D, Oakes D, Ortiz N, Yee M, Yih C, Sitapara K, Schulz J, Kohan L, Rosenburg J, Schwechter E, Chan F, Gonzalez D, Baker C. Percutaneous Ultrasound-Guided Tenotomy of the Iliotibial Band for Trochanteric Pain Syndrome: A Longitudinal Observational Study With One-Year Durability Results. Pain Physician. 2023 Jul;26(4):393-401.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate how an ultrasound-guided percutaneous procedure, TENEX, can help people with chronic hip pain resulting from a condition called Greater Trochanteric Pain Syndrome (GTPS) and to characterize the efficacy of percutaneous tenotomy (PUT) using TENEX®, a device used for the treatment of various tendinopathies. In this study an ultrasound (US) is performed to guide the partial release of gluteus medius and minimus and Iliotibial band tendons in patients diagnosed with refractory Greater Trochanteric Pain Syndrome (GTPS) vs control. The investigator team hypothesizes that the new TENEX can improve the pain level for individuals with GTPS to help those individuals perform their activities of daily living (ADLs), e.g., walking, standing, and side-lying, as well as demonstrate less medication utilization. The study predicts that this percutaneous outpatient procedure can decrease pain, increase mobility, and decrease medication utilization.\n\nThe study team hypothesizes that PUT can improve the pain level and function for individuals suffering with GTPS. The study will assess walking, standing, and side-lying tolerance, as well as medication utilization. The investigator team predicts that this percutaneous outpatient procedure can decrease pain and medication utilization while increasing mobility.', 'detailedDescription': "Greater trochanteric pain syndrome (GTPS) is one of the most common causes of lateral hip pain in adults. GTPS is repetitive overload tendinopathy of the gluteus medius (GMed) and Iliotibial band (ITB), which play a primary role in hip abduction and pelvic stabilization in walking, stair climbing, running and standing on one leg. It is thought that the core pathology is greater trochanteric bursitis (TB) with or without coexisting gluteal tendinopathy. Some common etiologies include prolonged excessive pressure to the area, injury to the side of the hip, and repetitive movements; however, local steroid injections to the greater TB are not often successful over the long-term. The best estimates of prevalence are from a large, community-based study with over 3000 adults aged 50 to 70 years, in which unilateral GTPS was present in 15 percent of women and 6.6 percent of men. Patients who have not improved after at least 12 months of conservative medical management (CMM), including physical therapy, oral medications, or a local steroid injection have no other conservative treatment recourse. Open surgery for GMed or ITB tears is not recommended unless a tear is diagnosed on MRI. Based on a published study, a 60% improvement was shown in pain with the performance of TENEX of the GMed.\n\nThe purpose of this project is to study the outcome of GMed and ITB PUT on CMM refractory GTPS. We want to quantify and show the scales of the pain in pre-operative and post-treatment cases. We also want to see how effective the surgery is in specific terms of pain levels because GTPS is a pain syndrome and reduction in pain level is the most important clinical factor.\n\nPatient Reported Outcome Measure (PROM) is one of the main outcomes that medical research is validated with and through this study we want to show the most important outcome of GTPS i.e., pain level (PROM for GTPS). Previous studies which focused on surgical outcomes have been mostly single-center trials.\n\nPain and mobility impact patients' Quality of Life (QoL) and medical cost burden due to unemployment, psychosocial well-being, and functional dependence. The standard of care offered to address the pain and mobility needs of those with GTPS is to provide CMM, followed by open or arthroscopic surgery if surgery is indicated. However, there is a treatment gap for those patients who have failed CMM and are not surgical candidates. The authors submit that TENEX of the GMed and ITB may address this gap. The results from this research may have broad impacts on the treatment algorithm for patients with GTPS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-90\n* People with GTPS of all different levels and etiologies confirmed with MRI or CT scan\n* Ability to give informed consent forms independently\n* Failed conservative medical treatment for at least 6 months\n\nExclusion Criteria:\n\n* Significant mobility restrictions; people using wheelchairs\n* Pregnancy\n* Previous surgery to the GMed or ITB'}, 'identificationModule': {'nctId': 'NCT05710627', 'acronym': 'RCT GTPS', 'briefTitle': 'Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Evaluation of Percutaneous Tenotomy of the Gluteus Medius and Iliotibial Band for Greater Trochanteric Pain Syndrome (GTPS): A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2022-14588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'TENEX device will be used', 'interventionNames': ['Device: TENEX']}], 'interventions': [{'name': 'TENEX', 'type': 'DEVICE', 'description': 'Use of TENEX device for sectioning of the gluteus medius and ITB tendons.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tahereh Naeimi, MD', 'role': 'CONTACT', 'email': 'tnaeimi@montefiore.org', 'phone': '347-977-8678'}, {'name': 'Sayed E. Wahezi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Tahereh Naeimi, MD', 'role': 'CONTACT', 'email': 'tnaeimi@montefiore.org', 'phone': '3479778678'}], 'overallOfficials': [{'name': 'Sayed E. Wahezi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}